Device and methods for port-access multivessel coronary artery bypass surgery

ABSTRACT

Surgical methods and instruments are disclosed for performing port-access or closed-chest coronary artery bypass (CABG) surgery in multivessel coronary artery disease. In contrast to standard open-chest CABG surgery, which requires a median stemotomy or other gross thoracotomy to expose the patient&#39;s heart, port-access CABG surgery is performed through small incisions or access ports made through the intercostal spaces between the patient&#39;s ribs, resulting in greatly reduced pain and morbidity to the patient. In situ arterial bypass grafts, such as the internal mammary arteries and/or the right gastroepiploic artery, are prepared for grafting by thoracoscopic or laparoscopic takedown techniques. Free grafts, such as a saphenous vein graft or a free arterial graft, can be used to augment the in situ arterial grafts. The graft vessels are anastomosed to the coronary arteries under direct visualization through a cardioscopic microscope inserted through an intercostal access port. Retraction instruments are provided to manipulate the heart within the closed chest of the patient to expose each of the coronary arteries for visualization and anastomosis. Disclosed are a tunneler and an articulated tunneling grasper for rerouting the graft vessels, and a finger-like retractor, a suction cup retractor, a snare retractor and a loop retractor for manipulating the heart. Also disclosed is a port-access topical cooling device for improving myocardial protection during the port-access CABG procedure. An alternate surgical approach using an anterior mediastinotomy is also described.

This application is a continuation of co-pending U.S. patent applicationSer. No. 09/019,014, filed Feb. 5, 1998 now abandoned, which is adivision of U.S. patent application Ser. No. 08/486,941, filed Jun. 7,1995, now U.S. Pat. No. 5,799,661, which is a continuation-in-part ofU.S. patent application Ser. No. 08/281,891, filed Jul. 28, 1994, nowU.S. Pat. No. 5,735,290, which itself is a continuation-in-part ofcopending U.S. patent application Ser. No. 08/023,778, filed Feb. 22,1993 now U.S. Pat. No. 5,452,733. The complete disclosures of theserelated U.S. patent applications are hereby incorporated herein byreference for all purposes.

FIELD OF THE INVENTION

The present invention relates generally to devices and methods forperforming thoracoscopic cardiac procedures. More particularly, thepresent invention relates to devices and methods for performing coronaryartery bypass graft (CABG) surgery for multivessel coronary arterydisease through port-access or closed-chest thoracoscopic methods.

BACKGROUND OF THE INVENTION

Coronary artery disease remains the leading cause of morbidity andmortality in Western societies. Coronary artery disease is manifested ina number of ways. For example, disease of the coronary arteries can leadto insufficient blood flow resulting in the discomfort and risks ofangina and ischemia. In severe cases, acute blockage of coronary bloodflow can result in myocardial infarction, leading to immediate death ordamage to the myocardial tissue.

A number of approaches have been developed for treating coronary arterydisease. In less severe cases, it is often sufficient to treat thesymptoms with pharmaceuticals and lifestyle modification to lessen theunderlying causes of disease. In more severe cases, the coronaryblockage(s) can often be treated endovascularly using techniques such asballoon angioplasty, atherectomy, laser ablation, stents, hot tipprobes, and the like.

In cases where pharmaceutical treatment and/or endovascular approacheshave failed or are likely to fail, it is often necessary to perform acoronary artery bypass graft procedure using open surgical techniques.Such techniques require that the patient's sternum be opened and thechest be spread apart to provide access to the heart. A source ofarterial blood is then connected to a coronary artery downstream from anocclusion while the patient is maintained under cardioplegia and issupported by cardiopulmonary bypass. The source of blood is often theleft or right internal mammary artery, and the target coronary arterycan be the left anterior descending artery, circumflex artery, rightcoronary artery or any one of their branches which might be narrowed oroccluded.

While very effective in many cases, the use of open surgery to performcoronary artery bypass grafting is highly traumatic to the patient. Theprocedure requires immediate postoperative care in an intensive careunit, a total period of hospitalization of seven to ten days, and arecovery period that can be as long as six to eight weeks.

It would therefore be desirable to provide other, less traumatic methodsand techniques for performing coronary artery bypass grafting. It wouldbe particularly desirable if such techniques did not require opening ofthe patient's sternum, and might be even more desirable if suchtechniques could be performed using thoracoscopic methods. Suchthoracoscopic methods could decrease morbidity and mortality, cost, andrecovery time when compared to conventional open surgical coronarybypass procedures. In addition, such methods could be even moreefficacious than open-surgical bypass procedures.

Treatment of multivessel coronary artery disease involves reroutingmultiple conduits to supply blood to the blocked coronary arteriesdownstream of the blockages. Typical conduits used for CABG surgery inmultivessel disease include arterial conduits, such as the left internalmammary artery (LIMA), the right internal mammary artery (RIMA) or theright gastroepiploic artery (RGEA), or venous conduits such as thegreater saphenous vein (GSV) or the lesser saphenous vein (LSV). Often acombination of these and other conduits is necessary to achieve completerevascularization of the obstructed coronary arteries. Open-chestapproaches to treatment of multivessel coronary artery disease aredescribed in Alternative Bypass Conduits and Methods for SurgicalCoronary Revascularization, by Grooters and Nishida, Futura PublishingCompany, Inc., Armonk, N.Y., 1994. Other references for standardopen-chest methods of coronary artery bypass surgery include: CardiacSurgery, by Kirklin and Barratt Boyes, John Wiley & Sons, Inc. New York,1993 (2nd Ed.), and Rob and Smith's Operative Surgery, Cardiac Surgery,The C V Mosby Co. St Louis, Mo. 1983 (4th Ed.).

A major challenge of thoracoscopic CABG surgery in multivessel diseaseis the ability to visualize and anastomose all of the coronary arteriesthrough a limited number of access ports in order to minimize the traumato the patient. This is made more difficult because many of preferredanastomosis sites on the branches of the right coronary artery and thecircumflex artery are on the posterior aspect of the heart and thereforeare difficult to access and to visualize with the heart in situ.Operating on the heart in situ would require separate access ports forthe left coronary artery and each of the right coronary artery and thecircumflex artery. Making this many access ports in the patient's chestwould undermine the atraumatic aspect of the thoracoscopic approach. Inopen-chest CABG surgery, this problem is solved by withdrawing the heartfrom the pericardial sac and manipulating it to expose the arteries onthe posterior aspect. No instruments currently exist for manipulatingthe heart within the closed chest of the patient, making it difficult toduplicate the close-chest procedure with thoracoscopic techniques.Devices and methods are therefore necessary for manipulating the heartwithin the patient's closed chest to expose each of the coronaryarteries for visualization and anastomosis.

The additional length of time required for performing multipleanastomoses in multivessel CABG surgery also poses difficulties in termsof myocardial preservation during the lengthy procedure. In openprocedures additional myocardial protection can be provided by topicalhypothermia of the heart to reduce oxygen demand by the myocardium. Theinstruments and systems currently available for topical hypothermia incardiac surgery are not suited for thoracoscopic techniques. New devicesand methods are therefore necessary for cooling the heart within thepatient's closed chest to extend myocardial preservation during themultivessel CABG procedure.

SUMMARY OF THE INVENTION

The present invention describes devices and methods for performingport-access or closed-chest CABG surgery to treat multivessel coronaryartery disease. All of the major steps of the port-access CABG procedureare performed through small percutaneous access ports to avoid thenecessity of a median sternotomy or other gross thoracotomy, as requiredin prior open-chest approaches. The methods of the present inventioninclude the steps of dissecting one or more conduit vessels, preferablyarterial conduits, from their native locations, rerouting the conduitvessels to the heart and grafting the conduit vessels onto the blockedcoronary arteries downstream of the blockages.

Generally, the step of dissecting the conduit vessels from their nativelocations or the “takedown” is performed through small access portsusing endoscopic visualization. In the case of a LIMA or RIMA takedown,the access ports are made into the patient's thoracic cavity through theintercostal spaces and visualization is achieved using a flexiblethoracoscope. Rerouting the LIMA involves redirecting the distal end ofthe LIMA to the desired anastomosis site. The RIMA may be reroutedanteriorly of the heart or it may be tunneled through the transversesinus to reach the desired anastomosis site. In the case of an RGEAtakedown, the access ports are made into the patient's abdomen andvisualization is achieved using a laparoscope. Rerouting the RGEAinvolves tunneling the distal end of the RGEA through a hole in thediaphragm to reach the desired anastomosis site on the heart. If venousgrafts, such as the GSV, or other free grafts are used in place of or inaddition to the arterial conduits, then the takedown or harvesting ofthe graft is performed by open or closed surgical techniques asappropriate and the graft is rerouted to the patient's chest foranastomosis.

Specialized instruments for facilitating the takedown and reroutingsteps are provided as part of the present invention. One instrumentprovided is a thoracoscopic tunneler for directing an arterial conduitthrough the transverse sinus or other tunneling path. One embodiment ofa tunneler has an elongated shaft with a curved, rigid distal end with ahole through the distal tip for passing a tape or silastic tube throughthe transverse sinus to retract the aorto-pulmonary trunk to facilitatepassage of the arterial conduit through the transverse sinus. Anotherembodiment of a tunneler has an elongated shaft with an articulateddistal end with a grasper for reaching through the transverse sinus tograsp the arterial conduit and draw it through the transverse sinus tothe desired anastomosis site. The two tunneling instruments may be usedseparately or in combination. In addition, a specialized thoracoscopicelectrosurgical device may be provided to facilitate takedown of thearterial conduits. A suitable thoracoscopic electrosurgical device forthis application is described in co-owned, copending patent application,Ser. No. 08/336,359, filed Nov. 8, 1994, the entire disclosure of whichis hereby incorporated by reference.

The step of grafting the conduit vessels onto the heart is accomplishedunder direct visualization using a cardioscopic microscope insertedthrough a visualization port into the patient's thoracic cavity madethrough an intercostal space in the anterior wall of the chest.Additional surgical instruments are inserted through auxiliary portsinto the patient's thoracic cavity to perform the anastomosis of theconduit vessels to the coronary arteries. The devices and methods of thepresent invention are devised to minimize the trauma to the patient bymaking it possible to visualize and access all aspects of the heart froma single centrally located visualization port by manipulating the heartwithin the patient's closed chest with instruments inserted through theauxiliary access ports or through the takedown ports which remain fromthe takedown step. Generally, the distal end of each conduit vessel orgraft is anastomosed to a coronary artery downstream of a blockage.Additionally, the conduit vessels may be sequentially grafted to morethan one coronary artery or branch to form a “skip graft”. If freegrafts are used an additional step of creating a proximal anastomosismust be performed. The proximal end of the graft may be anastomosed tothe ascending aorta or to another of the conduit vessels to form aY-graft. The step of making the proximal anastomosis may be performedbefore or after the distal anastomosis, depending on the preferences ofthe surgeon.

Specialized instruments are provided for manipulating the heart withinthe closed chest of the patient to rotate the desired anastomosis siteinto the visual field of the cardioscopic microscope. The specializedinstruments include retractors which can manipulate the heart fromoutside of the body through one or more of the access ports. Oneembodiment of a retractor has an elongated shaft with a handle at theproximal end and a curved, finger-like manipulator at the distal end.The curved, finger-like manipulator may be covered with an absorbentand/or frictional material to improve its effectiveness at retracting,rotating and manipulating the heart. Another embodiment of a retractorhas an elongated tubular shaft with a suction cup-shaped manipulator atthe distal end. A vacuum is applied between the suction cup manipulatorand the surface of the heart to grip the heart. The distal surface ofthe suction cup manipulator may have a textured or highly frictionalsurface to increase the grip on the surface of the heart, especially ina direction tangential to the surface. The retractor can thus be used toretract or rotate the heart in any direction to expose the desiredanastomosis site.

Another aspect of the present invention is to provide myocardialprotection to the heart for the duration of the surgical procedure. Afirst component of the myocardial protection is to provide a means forestablishing cardiopulmonary bypass (CPB) without the need forperforming a thoracotomy or other grossly invasive procedure. Onenoninvasive method of establishing CPB involves the insertion of anendoaortic occlusion catheter into the ascending aorta through apercutaneous puncture into a peripheral artery. An inflatable occlusionballoon on the distal end of the catheter is used to partition theascending aorta between the coronary ostia and the brachiocephalicartery to isolate the heart and coronary arteries from the remainder ofthe arterial system while it is supported on cardiopulmonary bypass.Cardioplegic solution to temporarily stop the heart from beating may beinfused into the coronary arteries through the catheter and/or through aretroperfusion catheter percutaneously inserted in the coronary sinus.This method is more completely described in co-owned, copending patentapplication, Ser. No. 08/281,891, filed Jul. 28, 1994.

Another relatively noninvasive method of establishing CPB involves usinga thoracoscopic cross-clamp to isolate the heart and coronary arteriesfrom the remainder of the arterial system while it is supported oncardiopulmonary bypass. The thoracoscopic cross-clamp is inserted intothe patient's thoracic cavity through an access port. Co-owned,copending patent application, Ser. No. 08/173,899, filed Dec. 27, 1993,the entire disclosure of which is hereby incorporated by reference,describes a specialized thoracoscopic cross-clamp suitable use with thepresent invention and a method of its use for isolating the heart andestablishing CPB.

A second component of the myocardial protection is to provide a meansfor applying topical hypothermia to the heart to reduce oxygen demand bythe myocardium while the patient is on cardiopulmonary bypass andparticularly while the heart is under cardioplegic arrest. A specializedtopical hypothermia system that can be applied thoracoscopically throughsmall access ports into the chest is provided as part of the presentinvention. The topical hypothermia system includes a flexible heatexchanger which is collapsible to fit through an access cannula insertedinto an intercostal space. The heat exchanger is deployable to anexpanded position once it is inside of the thoracic cavity. The heatexchanger is placed in thermal contact with the heart and a coolingfluid is circulated from outside the body through cooling passageswithin the heat exchanger. The temperature of the heart can be loweredfor the duration of the procedure to reduce oxygen demand. The heatexchanger can also be used for warming the heart at the end of theprocedure by circulating a warm fluid through the cooling passages.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the takedown step for using the left internal mammaryartery (LIMA) or the right internal mammary artery (RIMA) as an arterialbypass conduit.

FIG. 2 shows the tunneling of the RIMA through the transverse sinus(TS).

FIG. 3 shows the laparoscopic takedown of the right gastroepiploicartery (RGEA).

FIG. 4 shows the tunneling of the RGEA through the diaphragm into thethoracic cavity.

FIG. 5 shows the operative ports for performing the anastomosis of thearterial conduits onto the coronary arteries.

FIG. 6 shows a position of the heart for performing an anastomosis tothe right coronary artery (RCA) or the posterior descending (PDA)branch.

FIG. 7 shows an alternate position of the heart for performing ananastomosis to the RCA or the PDA.

FIG. 8 shows the position of the heart for performing an anastomosis tothe circumflex artery (Cx) or the obtuse marginal (OM) branches.

FIG. 9 shows the position of the heart for performing an anastomosis tothe left anterior descending artery (LAD).

FIGS. 10-15 show the step-by-step sequence of creating an end-to-sideanastomosis.

FIG. 16 shows the heart of the patient with multiple completed bypassgrafts.

FIGS. 17-18 show the step-by-step sequence of creating a side-to-sideanastomosis.

FIG. 19 shows the heart of the patient with sequential anastomoses on a“skip graft”.

FIG. 20 shows the heart of the patient with a saphenous vein bypassgraft.

FIG. 21 shows the heart of the patient with a Y-graft.

FIG. 22 shows a first embodiment of a tunneler for retracting thepulmonary trunk away from the transverse sinus.

FIG. 23 shows a schematic diagram of a patient's heart with the tunnelerof FIG. 22 in use.

FIG. 24 shows a second embodiment of a tunneler having an articulatingdistal end.

FIG. 25 is an enlarged detail drawing of the multilink articulator onthe distal end of the articulating tunneler of FIG. 24.

FIG. 26 shows an embodiment of the articulating tunneler of FIG. 24 witha grasper on the distal end for grasping the RIMA and drawing it throughthe transverse sinus.

FIG. 27 shows a schematic diagram of a patient's heart with thearticulating tunneler of FIG. 26 in use.

FIG. 28 shows a first embodiment of a heart retractor with a finger-likemanipulator on the distal end.

FIG. 29 shows an alternate embodiment of a heart retractor having afinger-like manipulator combined with a suction irrigation lumen.

FIG. 30A shows a die-cutting pattern for the covering material to coverthe finger-like manipulator of FIG. 28. FIG. 30B shows an enlargeddetail drawing of the die-cutting pattern of FIG. 30A.

FIG. 31 shows a cross section of a patient showing the heart retractorof FIG. 28 in use.

FIG. 32 shows the heart retractor of FIG. 28 fixed to the operatingtable to stabilize the heart.

FIG. 33A shows a side view of a second embodiment of a heart retractorhaving a suction cup-shaped manipulator on the distal end. FIG. 33Bshows a longitudinal cross section of the distal end of the heartretractor of FIG. 33A. FIG. 33C shows a distal end view of the heartretractor of FIG. 33A.

FIG. 34 shows a cross section of a patient showing the heart retractorof FIG. 33 in use.

FIG. 35 shows the heart retractor of FIG. 33 used to rotate the heart toexpose the Cx and the OM branches on the left aspect of the heart.

FIG. 36 shows a third embodiment of a heart retractor with a flexiblesnare on the distal end for manipulating the heart.

FIG. 37 shows the heart retractor of FIG. 36 in a predeployed positionfor insertion through an access cannula.

FIG. 38 shows a cross section of a patient showing the heart retractorof FIG. 36 in use.

FIG. 39 shows a fourth embodiment of a heart retractor for manipulatingthe heart in a predeployed position for insertion through an accesscannula.

FIG. 40 shows the heart retractor of FIG. 39 in a deployed position formanipulating the heart.

FIG. 41 shows a cross section of a patient showing the heart retractorof FIG. 39 in use.

FIG. 42 shows a first embodiment of a topical hypothermia device forcooling a patients heart to improve myocardial protection duringport-access cardiac surgery.

FIG. 43 shows the topical hypothermia device of FIG. 42 in a predeployedposition for insertion through an access port.

FIG. 44 shows the topical hypothermia device of FIG. 42 in a deployedposition.

FIG. 45 shows the topical hypothermia device of FIG. 42 in use withinthe chest of a patient.

FIG. 46 shows a second embodiment of a topical hypothermia device forcooling a patients heart to improve myocardial protection duringport-access cardiac surgery.

FIG. 47 shows the topical hypothermia device of FIG. 46 in a deployedposition.

FIG. 48 shows a first embodiment of an anterior mediastinotomy approachfor performing closed-chest multivessel CABG surgery.

FIG. 49 shows a second embodiment of an anterior mediastinotomy approachfor performing closed-chest multivessel CABG surgery.

FIG. 50 shows a top view of a fiberoptically illuminated oval accesscannula.

FIG. 51 shows a side view of the fiberoptically illuminated oval accesscannula of FIG. 50.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The Surgical Method

FIG. 1 is a schematic view of a patient's thorax illustrating thetakedown step of the port-access CABG procedure. The takedown stepshould be performed while the patient is under general anesthesia, butbefore the patient has been placed on cardiopulmonary bypass. If theLIMA is to be used as an arterial bypass conduit, a series of accessports are created on the left lateral side of the patient's chest, asshown in FIG. 1. The access ports are created by incising the skin witha scalpel between two of the patient's ribs, then an access cannula 112with a trocar is pushed through the intercostal space. Preferably, aself-anchoring access cannula 112 with a 10-12 mm internal diameter isused for the takedown ports. The placement of the access ports is highlyvariable, depending on the preferences of the surgeon and the anatomy ofthe patient which is assessed fluoroscopically before the operation toverify the preferred locations.

In one preferred embodiment of the method, to allow the takedown of theLIMA, a first access port 103 is placed in the third intercostal space13 on the left lateral side of the patient's chest, a second access port104 is placed in the fifth intercostal space 15, and a third access port105 is placed in the sixth intercostal space 16 in a slightly moreanterior position from the first two. Meanwhile, the left and rightbronchi are individually intubated just below the bifurcation of thetrachea so that the lungs can be individually ventilated. The left lungis deflated to provide clearance between the lung and the left anteriorwall of the thoracic cavity while the patient is ventilated through theright lung. A flexible thoracoscope 111 is inserted through one of theaccess ports, such as the third access port 105 as shown in FIG. 1. Thedistal end of the flexible thoracoscope 111 can be directed toward theanterior wall of the thoracic cavity just to the left of the sternum Sto view the LIMA. Elongated instruments, such as an electrosurgicaldevice 110 and a grasper 109, are inserted through the remaining ports104, 103 to dissect the LIMA from the anterior wall of the chest. TheLIMA is dissected with an attached pedicle. Side branches of the LIMAare ligated with ligating clips, applied with a thoracoscopic clipapplier, as the LIMA is dissected from the surrounding tissue. A lengthof LIMA of 15-30 cm is dissected from the wall to provide enough lengthto reach the chosen anastomosis site. When a sufficient length of LIMAhas been dissected, two ligating clips are placed side-by-side near thedistal end of the LIMA and the vessel is transected between them.

If the patient's lungs are ventilated by high frequency “jet”ventilation, then the RIMA can also be harvested from the access ports103, 104, 105 on the left side of the patient's chest, provided thepatient's chest has ample space between the heart and the anterior wallof the thoracic cavity. To do this, both lungs are partially deflatedwhile continuing to ventilate, thereby allowing clearance to reach theRIMA from the left side of the chest. After dissecting the mediastinalpleura, the distal end of the thoracoscope 111 is directed toward theanterior wall of the thoracic cavity just to the right of the sternum Sto view the RIMA and the RIMA is taken down in a similar fashion to theLIMA.

If conventional ventilation is used, sufficient ventilation cannot beachieved with both lungs partially deflated, so this option is notavailable. In this case, access ports 106, 107, 108 symmetrical to theleft hand ports are placed in the lateral right side of the chest,typically in the third 13, fifth 15 and sixth 16 intercostal spaces. Theright lung is deflated to provide clearance between the lung and theanterior wall of the thoracic cavity while the left lung is ventilated.The flexible thoracoscope 111 is inserted through one of the accessports and instruments, such as the electrosurgical device 110, graspers109 and/or a clip applier, are inserted through the remaining ports todissect the RIMA from the anterior chest wall. A length of 15-30 cm ofRIMA with an attached pedicle is dissected from the chest wall toprovide enough length to reach the chosen anastomosis site. When asufficient length of RIMA has been dissected, two ligating clips areplaced side-by-side near the distal end of the RIMA and the vessel istransected between them.

When rerouting the RIMA to the anastomosis site, two paths are possible.The currently preferred path is through the transverse sinus TS which isa natural passage behind the aorta A and the pulmonary artery P leadingfrom the right side of the heart H to the left side. The RIMA istunneled through the transverse sinus TS by passing an instrument, suchas the articulated tunneling grasper 150 described below in relation toFIG. 24, through the transverse sinus TS and drawing the distal end ofthe RIMA back through the transverse sinus TS, as shown in FIG. 2. (notabene: The patient's chest has been shown with the ribs R cut away inFIG. 2, and subsequent figures, solely for the purposes of illustration.An important feature of the port-access surgical method of the presentinvention is that the ribs and the sternum remain intact throughout thesurgical procedure.) To facilitate the tunneling operation, a tunneler140, such as the one described below in relation to FIG. 22, can be usedto retract the pulmonary trunk P to allow easier passage of the RIMAthrough the transverse sinus TS. The second path for rerouting the RIMAis across the anterior side of the heart H. This routing of the RIMA isnot currently preferred by most surgeons in open-chest CABG operationsbecause the oscillating saw commonly used for doing the sternotomy inredo CABG operations can cause damage to the RIMA if it is placed in ananterior position. However, it is interesting to note that redo CABGwill not require the oscillating saw to open the sternotomy if theoriginal CABG operation was done with port-access techniques that do notrequire a sternotomy. The less traumatic reciprocating saw, commonlyused in first time CABG surgery, can be used if a redo operation isnecessary because it will be the patient's first stemotomy. As thetechniques for port-access CABG surgery advance, the simpler anteriorroute for the RIMA is likely to become the preferred path.

If a third arterial conduit is required for complete revascularizationof the heart or if either of the internal mammary arteries is notavailable, then the right gastroepiploic artery (RGEA) is the nextchoice. FIG. 3 shows the laparoscopic takedown step for the RGEA. Afirst laparoscopic access port 113 is placed above the umbilicus and asecond laparoscopic access port 114 is placed below the diaphragm. Athird 115 and fourth 116 access ports may be placed in the left andright side of the abdomen as shown for insertion of instruments. TheRGEA is dissected from the greater curvature of the stomach ST using anelectrosurgical device. Ligating clips are placed on branches of theRGEA running toward the omentum. Branches 117 running toward the stomachare preferably ligated with suture. A length of 15-30 cm of RGEA with anattached pedicle is dissected from the stomach to provide enough lengthto reach the chosen anastomosis site. When a sufficient length of RGEAhas been dissected, two ligating clips 118 are placed side-by-side nearthe distal end of the RGEA and the vessel is transected between them.

A hole 119 is made through the diaphragm D in an appropriate place forreaching the desired anastomosis site using an electrosurgical device.The distal end of the RGEA is tunneled upward through the diaphragm D asshown in FIG. 4. In FIG. 4, the rerouted RGEA is shown being anastomosedto the PDA on a heart H which has been retracted by the methodsdescribed below to expose the posterior aspect of the heart.

If a venous graft, such as the greater saphenous vein (GSV), is needed,a venous takedown procedure can be performed by known techniques toprovide a venous conduit. After harvesting, the vein can be prepared foruse as a graft outside of the body and inserted into the thoracic cavitythrough one of the access ports at the appropriate time in the graftingstep of the procedure.

Simultaneously with the takedown step or steps just described, thepatient can be prepared for cardiopulmonary bypass by cannulating thefemoral artery and the femoral vein using surgical cutdowns or thepercutaneous Seldinger technique. Additionally, an endoaortic occlusioncatheter may be positioned in the ascending aorta according to themethods described in co-owned, copending patent application Ser. No.08/281,891, filed Jul. 28, 1994. According to the methods describedtherein, an elongated endoaortic occlusion catheter is introduced into aperipheral artery, such as the femoral artery and advanced into theascending aorta. When it is time to establish CPB before the graftingstep described below, an occlusion balloon on the distal end of thecatheter is inflated to occlude the aortic lumen between the coronaryostia and the brachiocephalic artery. Once the balloon is inflated acardioplegic agent can be infused through a lumen in the catheter intothe aortic root and into the coronary arteries to induce cardiac arrest.Alternatively, a thoracoscopic cross-clamp may be introduced through oneof the access ports according to the methods described in co-owned,copending patent application Ser. No. 08/173,899, filed Dec. 27, 1993,the entire disclosure of which is hereby incorporated by reference.According to the methods described therein, an elongated thoracoscopiccross-clamp is introduced through one of the access ports and, at theappropriate time, clamped around the ascending aorta to occlude theaortic lumen. A cardioplegic agent may be introduced antegrade into theaortic root or retrograde through the coronary sinus to induce cardiacarrest. This is in preparation for the grafting step of the method ofthe present mention which follows.

At this point in the procedure the pericardium is opened to expose theheart as completely as possible. Using thoracoscopic observation,grasping instruments and cutting instruments, such as knives, scissorsand/or an electrosurgical device are inserted through the takedown ports103, 104, 105 and a vertical slit beginning at or near the aorticreflection and extending to the apex of the heart is made in thepericardium. Thoracoscopic bipolar electrosurgical cutting scissors,such as model 3803 bipolar scissors from Everest Medical Corporation,Minneapolis, Minn., have proven to be an effective instrument forperforming the pericardiotomy. The pericardium is divided to expose thesurface of the heart H to view.

FIG. 5 shows the operative ports for performing the anastomosis of thearterial conduits onto the coronary arteries. A visualization port 120is placed in the anterior wall of the chest, typically through thefourth intercostal space 14, about 1-3 cm from the sternum S. Theprecise placement of the visualization port 120 is determined by theposition of the heart H within the patient's chest. A probe, such as a22 gauge needle can be inserted percutaneously through the intercostalspace while observing the anterior wall of the thoracic cavity throughthe thoracoscope. When the needle is observed entering the thoraciccavity above the target position, for instance above the LAD when theheart is in its native position, the needle is removed and a trocar isused to create an access port at that position. An access cannula 121with an internal diameter of 10-12 mm is placed in the access port 120and the cardioscopic microscope (not shown) is inserted through thecannula. A cardioscopic microscope, adapted especially for thisport-access CABG procedure is available from Karl Zeiss, GmbH, Germany.The presently preferred configuration uses an OPMI® microscope, modelMDU or CS, with an NC31 microscope stand, an endoscopic adapter and aPort-Access StereoVision Probe. Other types of microscope-based anddirect visualization systems which are particularly well-suited for usein the method of the present invention are disclosed in co-owned,copending patent applications Ser. No. 08/135, 387, filed Oct. 8, 1993,and Ser. No. 08/227,366, filed Apr. 13, 1994, the complete disclosuresof which are hereby incorporated herein by reference. With themicroscope positioned in the visualization port 120, the left anteriordescending coronary artery (LAD) should be within the field of view ofthe microscope.

A number of instrument ports 122 are placed about 3-5 cm from thevisualization port to allow proper angulation of the instruments intothe field of view of the microscope. Typically, two ports 122 are placednear the sternum S in the third I3 and fourth 14 intercostal spaces andtwo more ports 122 are placed to the left of the visualization port inthe third I3 and fifth 15 intercostal spaces. An access cannula 123 withan internal diameter of 5 mm is placed in each of the instrument ports122.

Next the graft vessels, whether arterial or venous conduits, must beprepared for anastomosis. Preferably, the distal ends of the graftvessels are prepared outside of the body by passing the distal end ofthe graft out through one of the access ports. This simplifies theprocedure because the end of the graft can be prepared under directvisualization with magnifying surgical loupes and because standardsurgical instruments can be used for preparing the graft rather thanthoracoscopic instruments. The LIMA or RIMA can be passed out throughone of the thoracic access ports (e.g. access port 103 or 106 in FIG. 1)before rerouting or tunneling the vessel. The RGEA can be passed outthrough one of the abdominal access ports (e.g. access port 113 or 114in FIG. 3) before tunneling the RGEA through the diaphragm D. If thegraft vessel is too short to reach the exterior of the body through oneof the access ports, the following graft vessel preparation procedurecan also be carried out within the thoracic cavity using thoracoscopicinstruments and techniques. Prior to preparing the graft vessel, theblood flow into the vessel must be stopped by placing an atraumaticclamp (e.g. 124 in FIG. 4) on the upstream end of the vessel. Anatraumatic thoracoscopic bulldog clamp especially suited for this stepof the procedure is described in co-owned, copending patent applicationSer. No. 08/265,477, filed Jun. 24, 1994.

The graft vessel should be prepared by first determining the appropriatelength of the conduit in order to reach the desired anastomosis site.The distal end of the graft vessel should then be skeletonized bystripping the pedicle away from the artery for 5-10 mm. The distal endof the artery is transected to remove the ligating clip 118 that waspreviously applied. If desired, Papavarin may be injected into the lumenof the artery to dilate it and reverse any arterial spasm. Depending onthe technique preferred by the surgeon, the distal end of the graftvessel can be slit longitudinally to create a cobra head for theanastomosis. Once prepared the graft vessel is reinserted into thethoracic cavity through the access port.

When performing multiple anastomoses, it is preferable to do the mostdifficult or most difficult to reach anastomosis first. For example, anyanastomosis to the RCA or the PDA should be performed first since themost retraction of the heart is necessary. Following that, anyanastomosis to the Cx or the OM branches should be performed. Finally,any anastomosis to the LAD can be performed last. The RIMA, RGEA or avein graft may be used for anastomosis to the RCA or the PDA which areon the posterior aspect of the heart. Typically, the LIMA, RIMA or avein graft is used when a graft is needed for the Cx or the OM branchesbecause of their location on the left aspect of the heart. The LIMA, orthe RIMA if the LIMA has already been used for the Cx, may be used foranastomosis to the LAD which is on the anterior aspect of the heart.Because the manifestations of coronary artery disease are highlyvariable, the extent of the disease should be assessed fluoroscopicallybeforehand and the anastomosis sites and the best use of the availableconduits strategized carefully. The procedures for anastomosing to eachof the major anastomosis sites will now be described. These procedurescan be performed in combination to achieve complete revascularization ofthe heart.

FIG. 6 shows a first position of the heart H for performing ananastomosis to the right coronary artery (RCA) or the posteriordescending (PDA) branch. The heart H is manipulated from outside of thebody using instruments inserted through the instrument ports 122 or thetakedown ports 103, 104, 105 in the patient's chest. Using the heartretractor devices described below in connection with FIGS. 26 and 27 orany suitable means for manipulating the heart from outside of the body,the heart H is rotated approximately 180 degrees to the left of thepatient to position the RCA and/or PDA under the microscope in thevisualization port 120. With the heart H stabilized in this position,the distal extremity of the conduit vessel is approximated to the chosenanastomosis site and an end-to-side anastomosis is performed. The likelygraft vessels for the RCA and the PDA, which include the RIMA and theRGEA, are shown in phantom lines in FIG. 6. After completion of theanastomosis, the heart H is rotated back to its native position or tothe desired position for the next anastomosis.

FIG. 7 shows an alternate position of the heart H for performing theanastomosis to the RCA or the PDA. In this variation of the procedure,the heart H is rotated approximately 180 degrees about an axis 125 whichis at an approximately 45 degree angle to the sagittal axis of the body.Flipped upward this way, the RCA and the PDA are positioned under themicroscope in the visualization port 120. With the heart H stabilized inthis position, the distal extremity of the conduit vessel isapproximated to the chosen anastomosis site and an end-to-sideanastomosis is performed. The likely graft vessels for the RCA and thePDA, which include the RIMA and the RGEA, are shown in phantom lines inFIG. 7. After completion of the anastomosis, the heart H is rotated backto its native position or to the desired position for the nextanastomosis.

FIG. 8 shows the position of the heart H for performing an anastomosisto the circumflex artery (Cx) or the obtuse marginal (OM) branches. Inorder to access the Cx or the OM branches which are on the left aspectof the heart or the left posterior aspect of the heart, the heart H isrotated toward the right by 45 to 90 degrees using retractioninstruments inserted through the access ports (e.g. 103, 104, 105). Inthis position the Cx and/or the OM branches will be positioned under themicroscope in the visualization port 120. With the heart H stabilized inthis position, the distal extremity of the conduit vessel isapproximated to the chosen anastomosis site and an end-to-sideanastomosis is performed. The likely graft vessels for the Cx and the OMbranches, which include the LIMA and the RIMA, are shown in phantomlines in FIG. 8. After completion of the anastomosis, the heart H isrotated back to its native position or to the desired position for thenext anastomosis.

With the more difficult to reach anastomoses completed and the heart Hback in its native position, as shown in FIG. 9 the anastomosis to theLAD can now be completed. With the heart H in its native position, theLAD will be positioned under the microscope in the visualization port120. With the heart H stabilized in this position, the distal extremityof the conduit vessel is approximated to the chosen anastomosis site andan end-to-side anastomosis is performed. The likely graft vessels forthe LAD, which include the LIMA and the RIMA, are shown in phantom linesin FIG. 9.

Alternatively to manipulating the heart within the closed chest toexpose the different aspects, a second visualization port 126 andinstrument ports 127 can be opened on the right side of the chest, asshown in phantom lines in FIG. 5, to access the right coronary arteryRCA directly. In another alternative approach, right side access portsmay be used alone if only the right coronary artery RCA and/or theobtuse marginal OM branches are to be revascularized or if the patient'sanatomy favors a right side approach for multivessel revascularization.

FIGS. 10-15 show the step-by-step sequence of creating an end-to-sideanastomosis. Referring now to FIG. 10, an incision 95 is made in thewall of the coronary artery CA, where the incision has dimensionsselected to match those of the distal end of the internal mammary arterygraft IMA. The incision 95 is made by first piercing the arterial wallusing the tip of a scalpel (not illustrated). Scissors 96 are thenintroduced through the penetration and used to axially extend thepenetration, as illustrated at 97 in FIG. 11.

The internal mammary artery IMA can be joined to the extended incision97 in the coronary artery CA by a variety of techniques, includingsuturing, laser welding, microstapling, and the like. In a currentlypreferred embodiment of the method of the present invention, it ispreferred to use a continuous suturing technique as illustrated in FIGS.10-15. A length of suture 98 has needles 100 at either end, which aremanipulated using forceps 102 to join the distal end 101 of the internalmammary artery IMA graft to the opening created by the incision 97 inthe coronary artery CA, as shown in FIGS. 11-15. The instrument designspresently preferred for performing the coronary anastomosis aredescribed in copending application Ser. No. 08/194,946, filed Feb. 11,1994, the entire disclosure of which is hereby incorporated herein byreference. Alternatively, an interrupted suture technique for theanastomosis can be used, as described in Rob and Smith's OperativeSurgery, Cardiac Surgery for open-chest CABG surgery.

The presently preferred suture for port-access CABG surgery is adouble-armed suture of 8-10 cm length which was specially developed forthis procedure. The suture 98 has a first needle 100 on one end and asecond needle 100 on the other end. Preferably, the needles 100 are ⅜circle curved hardened stainless steel needles with tapered points. Theneedles 100 are preferably attached to the suture 98 by crimping.Alternatively, the needles 100 may be adhesively bonded to be suture 98.The preferred suture material 98 is a multifilament, expanded PTFEsuture material with a size between 8-0 and 6-0 USP, preferably 7-0 USP.Suitable suture material of this type is available from W. L. Gore,Corporation under the tradename Goretex®. A contrasting color which ishighly visible within the thoracic cavity, such as black, blue or white,is preferred for the suture material.

The configuration of this suture is especially advantageous for use inthe portaccess surgical CABG procedure. The suture can be inserted intothe thoracic cavity through an access port and manipulated usingthoracoscopic needle drivers to sew the anastomosis and to tie thesuture within the thoracic cavity. Standard sutures, which are normallymuch longer, are very difficult to manipulate within the closed chest,especially when tying the suture using thoracoscopic instruments. Theshort length of the suture allows the knots in the suture to be pulledtight within the confines of the thoracic cavity while grasping theneedles with the needle drivers. The multifilament, expanded PTFE suturematerial is much easier to handle and tie within the confines of thethoracic cavity than monofilament suture material which is generallystiffer and harder to handle. Additionally, the multifilament, expandedPTFE suture material has more resistance to damage than monofilamentwhen it is grasped directly by the needle drivers, as shown in FIGS. 11,14 and 15.

FIG. 16 shows the heart H of a patient after completion of a totalrevascularization for multivessel coronary artery disease usingport-access techniques. Three bypass grafts have been made, using theLIMA as a bypass to one of the OM branches of the Cx, the RIMA as abypass to the LAD, tunneled via the transverse sinus TS, and the RGEA asa bypass to the PDA, tunneled through the diaphragm.

A sequential grafting technique or “skip grafting” is useful forachieving total revascularization when the number of significantcoronary artery stenoses exceeds the number of available graft conduits.Sequential grafts are created by making a side-to-side anastomosis witha first coronary artery at an intermediate point on the graft vessel,then an end-to-side anastomosis between the distal end of the graftvessel and a second coronary artery. FIGS. 17-18 show the step-by-stepsequence of creating a side-to-side anastomosis between a graft vessel Gand a coronary artery CA. The side-to-side anastomosis is fashioned in adiamond-shaped manner, placing the graft vessel arteriotomy 128 at rightangles to the coronary arteriotomy 129. Small arteriotomies, 3-4 mm inlength, are used and six to eight continuous stitches 130 are placedthrough the coronary artery CA and the graft vessel G. An interruptedsuture technique can also be used. FIG. 19 shows the heart H of apatient with a completed sequential graft. The LIMA has been firstgrafted to the diagonal branch LD of the left anterior descendingcoronary artery using a side-to-side anastomosis 131, then grafted tothe LAD with an end-to-side anastomosis 132.

Free grafts using either arterial conduits or venous conduits can beused to augment the in situ arterial grafts. Generally, the proximal endof a free grafts is anastomosed to the ascending aorta A to provide anarterial blood source and the distal end of the graft is anastomosed toone of the coronary arteries. A common source of free grafts is thegreater saphenous vein. Other conduits used as free grafts include thelesser saphenous vein, the LIMA, the RIMA, the inferior epigastricartery, the splenic artery, the subclavian artery, and others. FIG. 20shows the heart H of a patient with a saphenous vein bypass graft SVG tothe LAD. The proximal anastomosis 133 can be created using suturetechniques similar to those described in connection with FIGS. 10-15above with the exception that a thoracoscopic tissue punch would be usedto create an aortotomy after the initial incision with a scalpel.Alternatively, the proximal anastomosis 133 can be created using ananastomosis staple device, such as those described in co-owned,copending patent application Ser. No. 08/394,333, filed Feb. 24, 1995,the entire disclosure of which is hereby incorporated by reference.

Free grafts can be combined with in situ grafts or other free grafts tocreate composite bypass grafts to help achieve total revascularizationfor multivessel disease. For example, a free graft can be anastomosed tothe distal end of an in situ graft like the LIMA or RIMA when there isinsufficient length of the graft after takedown. Alternatively, aY-graft can be created as an alternative to the sequential graftsdescribed above. FIG. 21 shows the heart H of a patient with a Y-graft.The Y-graft was created by joining the proximal end of a free rightinternal mammary artery graft F-RIMA to an intermediate point on a LIMAin situ graft with an end-to-side anastomosis 134, then grafting thedistal end of the RIMA to the Cx with an end-to-side anastomosis 135 andgrafting the distal end of the LIMA to the LAD with an end-to-sideanastomosis 136. Other conduits including arterial and venous grafts canbe combined in various combinations to create composite grafts.

Instrument Descriptions

FIGS. 22-47 show an armamentarium of instruments for facilitating theport-access multivessel CABG procedure. FIG. 22 shows a first embodimentof a tunneler 140 for retracting the pulmonary artery away from theascending aorta to facilitate tunneling the RIMA through the transversesinus TS. The tunneler 140 has an elongated shaft 141 of sufficientlength to reach the great vessels of the heart from the takedown portsin the left lateral side of the chest, typically 15-30 cm in overalllength. There is a handle 142 on the proximal end of the shaft 141. Thedistal portion 143 of the shaft is curved to facilitate passing thetunneler 140 through the transverse sinus TS from the left side of theheart. The distal tip 144 of the shaft is rounded to make it atraumatic.There is a hole 145 through the shaft 141 near the distal tip 144 of thetunneler 140. In use, a silastic tape 146 or elastomeric tube isthreaded through the hole 145 and the distal end of the tunneler isinserted through one of the takedown ports (e.g. 103 in FIG. 23). Underthoracoscope observation, the curved distal portion 143 is insertedbehind the pulmonary artery P and the ascending aorta A and passedthrough the transverse sinus TS to the right side of the heart, as shownin FIG. 23. When the distal tip 144 of the tunneler 140 emerges on theright side of the heart H, a grasper is inserted through one of theaccess ports, typically one of the takedown ports on the left lateralside of the chest, to grasp one side of the tape 146. The retractor 140is withdrawn and the ends of the tape 146 are passed out through theaccess ports, preferably one of the takedown ports located at the thirdor fourth intercostal space, and tension is placed on the tape 140 toretract the main pulmonary artery P and the ascending aorta A (theaorto-pulmonary trunk), thereby widening the transverse sinus TS. Withthe pulmonary artery P and the ascending aorta A retracted, a graspinginstrument, such as the articulated tunneling grasper 150 of FIG. 26,can more easily be reached through the transverse sinus TS.

A basic embodiment of the articulated tunneling grasper 150 is shown inFIG. 24. The articulated tunneling grasper 150 has an elongated tubularshaft 151 with a handle 152 on the proximal end. A multilink articulator153 is attached to the distal end of the shaft 151. The multilinkarticulator 153 is shown in detail in FIG. 25. The multilink articulator153 has a head 154 which attaches to the distal end of the shaft 151.Two links 155, 156 are pivotally attached to the head 154. The firstlink 155 is a straight link. The proximal end of the first link 155 ispivotally attached to the head 154. The second link 156 is an L-shapedlink with a long leg 157 that is approximately the same length as thefirst link 155, and a short leg 158 extending perpendicular from theproximal end of the long leg 157. The second link 156 is pivotallyattached to the head 154 at the proximal end of the long leg 157. Anactuator rod 159 that passes through the tubular shaft 151 connects theend of the short leg 158 with a sliding actuator button 160 on thehandle 152. The first link 155 and the second link 156 cross one anotherand their distal ends are pivotally attached to a third link 161. Thethird link 161 is an L-shaped link with a long leg 162 extendingdistally, and a short leg 163 extending perpendicular from the proximalend of the long leg 162. When the actuator rod 159 is in its neutralposition the multilink articulator 153 is in a relatively straightposition, as shown in FIG. 24 by solid lines 153. When the actuator rod159 is moved distally with respect to the head 154, it pivots the secondlink 156 clockwise, as shown in FIG. 24 by phantom lines 153′. Therelative motion of the first 155 and second links 156, in turn, pivotsthe third link 161 clockwise, as shown. When the actuator rod 159 ismoved proximally with respect to the head 154, it pivots the second link156 counterclockwise, as shown in FIG. 24 by phantom lines 153″. Therelative motion of the first 155 and second links 156, in turn, pivotsthe third link 161 counterclockwise. The distal end of the multilinkarticulator 153 can thus pivot approximately 90 degrees in eitherdirection.

Various end effectors can be attached to the distal end of the multilinkarticulator 153 for performing different tasks. The possible endeffectors include a simple hole 164, as shown in FIG. 24, for placing atape through the transverse sinus TS for retracting the aorto-pulmonarytrunk, or a heart retraction device, such as a suction retractor orfinger retractor, as discussed in more detail below, or a graspingmechanism, such as a cable-actuated grasper.

In one particularly preferred embodiment, shown in FIG. 26, acable-actuated grasper 165 is mounted on the distal end of the multilinkarticulator 153 shown in FIG. 24. The grasper 165 has a first 166 andsecond 167 jaw with grasping surfaces on the facing surfaces of the jaws166, 167. At least one of the jaws 166, 167, and preferably both jaws.are pivotally attached to the distal end of the third link 166, 167. Anactuator cable (not shown) extends from a control button 168 on thehandle 152, through the tubular shaft, and to a linkage connected to thegrasper jaws 166, 167. The jaws of the grasper 166, 167 can be actuatedto open and close using the control button 168.

In use, the articulated tunneling grasper 150 is inserted through one ofthe takedown ports 103, 104, 105 in a straight position. The distal endof the grasper 165 is inserted behind the pulmonary artery P and theascending aorta A, and through the transverse sinus TS, as shown in FIG.27. The multilink articulator 153 is actuated to assume an appropriatecurve to pass easily through the transverse sinus TS. Once the distalend of the grasper 165 emerges from the transverse sinus TS on the rightside of the heart H, as shown in FIG. 27, the multilink actuator 153 canbe used to manipulate the grasper 165 closer to the RIMA. Anothergrasper may be inserted through another access port to assist withhandling the RIMA to the articulated tunneling grasper 150. The grasper165 is opened, then closed to grasp the pedicle of the RIMA so as not todamage the vessel. The articulated tunneling grasper 150, with the RIMAin its grasp, is withdrawn through the transverse sinus TS to the leftside of the heart H. The RIMA has thus been tunneled through thetransverse sinus TS from the right side of the heart to the left side,as discussed above in relation to FIG. 2.

Tunneling the RIMA through the transverse sinus TS from the right sideof the heart to the left side is the currently preferred path forrerouting the RIMA for attachment to the Cx or the OM branches.Alternatively, the RIMA can be routed across the anterior side of theheart using the articulated tunneler or another thoracoscopic graspingdevice. When rerouting a graft vessel, particularly when tunnelingthrough a space such as the transverse sinus TS, it is important toavoid twisting or kinking the graft vessel. One way to avoid twistingthe vessel is to mark a line along the vessel which can serve as anindicator of whether the vessel is straight. For instance, the vesselcan be marked by drawing a line along the vessel or on the pedicle witha surgical marker containing a nontoxic ink, such as methylene blue. Thevessel is preferably marked before takedown to assure that the vessel isin a straight condition when it is marked. Alternatively, the clips orsutures that are used to ligate side branches of the vessel duringtakedown can be used as markers to determine if the graft vessel isstraight when it is rerouted.

FIG. 28 shows a first embodiment of a heart retractor 170 with afinger-like manipulator 171 on the distal end for rotating the heartwithin the closed chest of the patient to expose each of the coronaryarteries to be anastomosed. The retractor 170 has an elongated shaft 172of approximately 15-30 cm with a handle 173 on the proximal end of theshaft. The distal end of the retractor shaft is curved to create afinger-like manipulator 171. The curved manipulator 171 has a radius ofcurvature in one preferred embodiment of approximately 4.5 cm. Theradius of curvature in other embodiment can range from 3.5-6 cm. Thecurvature of the finger-like manipulator 171 subtends an arc ofapproximately 90 to 180 degrees. The finger-like manipulator 171 has anouter diameter of approximately 5-10 mm. The finger-like manipulator 171is preferably molded of a rigid plastic, such as ABS or nylon.Alternatively, the finger-like manipulator 171 can be made of metal,such as stainless steel. In one particular alternative embodiment, thefinger-like manipulator 171 is made of annealed 316 stainless steelwhich is malleable so that it can be manually bent to the desiredcurvature. The exterior of the finger-like manipulator 171 is coveredwith an absorbent and/or high friction material 174 to assist ingrasping and manipulating the heart. The covering 174 of the finger-likemanipulator 174 extends to the very distal end 175 of the manipulator171 and covers the rounded distal tip 175. The preferred material 174for covering the finger-like manipulator 171 is a nonwoven polyesterfabric, embossed with an open mesh pattern. The nonwoven polyester givesthe covering absorbancy, while the open mesh pattern improves thefriction of the surface. A fabric with a self-sticking adhesive surfaceis preferred for convenience in assembling the retractor. The currentlypreferred material for the covering 174 of the finger-like manipulator171 is a 2.4 oz. nonwoven, embossed polyester medical tape withWetstick™ adhesive available from Avery Dennison, Specialty TapeDivision, Painesville, Ohio.

Alternate materials for the covering 174 of the finger-like manipulator171 include nonembossed, nonwoven fabrics, such as polyester surgicalfelt. While the absorbancy of these materials is quite acceptable, thefriction of the smooth, nonembossed fabric is less than for embossedmaterials. Examples of acceptable materials in this category includeFastsorb 820 and Exsorbx 400 available from Berkshire Corp, GreatBarrington, Mass. or Surgical Felt 6077 or 6079 available from BARD,Vascular Surgery Division, Haverhill, Mass. Other materials suitable forcovering the finger-like manipulator 171 include woven materials andknit materials made of polyester, cotton or other fibers. Thesematerials also tend to have a lower coefficient of friction for grippingtissue. Another alternate material for the covering of the finger-likemanipulator 171 is a composite material, including a first layer of ahighly absorbent material, like surgical felt, and a second layer ofmesh-like material to increasing the coefficient of friction forgripping the surface of the heart.

The covering material 174 is preferably die cut in a pattern that easilyconforms to the shape of the finger-like manipulator 171. FIG. 30 showsa die-cutting pattern 176 for the covering material 174 to cover afinger-like manipulator 171 having a radius of curvature of 4.5 cm whichsubtends 180 degrees of arc, and an outer diameter of 8 mm, such as theone shown in FIG. 28. FIG. 30B shows an enlarged detail drawing of thedie-cutting pattern 176 of FIG. 30A. The self-adhesive covering material174 is cut to this pattern 176 and adhesively bonded to the exterior ofthe finger-like manipulator 171.

The absorbancy, combined with the texture of the covering 174, gives theretractor 170 a good frictional grip on the surface of the heart.Keeping the interface between the retractor surface and the surface ofthe heart dry is important for maintaining a good frictional grip.Another preferred embodiment of the retractor 170, shown in FIG. 29,combines suction irrigation with the retractor to augment the absorbancyof the covering material 174. In this embodiment, a suction lumen 177extends through the shaft 172 of the retractor 170 and through thefinger-like manipulator 171. A series of suction holes 178 connect thesuction lumen with the surface of the finger-like manipulator 171 on theinner curve of the distal end. A constant or intermittent suctionthrough the holes 178 will keep the covering material 174 dry to improvethe frictional grip on the surface of the heart.

In use, the retractor 170 is typically inserted into the thoracic cavitythrough one of the takedown ports 103, 104, 105 on the left lateral sideof the chest. The curved finger-like manipulator 171 of the retractor170 is hooked around the apex of the heart H, as shown in FIG. 31. Theretractor 170 can be used to rotate or translate the position of theheart H within the closed chest. For example, the retractor 170 can beused to roll the heart H toward the right side of the patient to exposethe Cx or the OM branches on the left aspect of the heart to themicroscope in the visualization port 120. This position of the heart His shown in FIG. 7. The retractor 170 can also be used to lift the apexof the heart and flip the heart 180 degrees to expose the RCA or PDA onthe posterior aspect of the heart H to view. This position of the heartH is shown in FIG. 9.

The retractor 170 can be fixed to the operating table 180 to stabilizethe heart H in the desired position, as shown in FIG. 32. A positioningdevice 182, such as those available from Omni-Tract Surgical Div.,Minneapolis, Minn. or Mediflex Medical Products, Islandia, N.Y., isattached to the operating table 180 and bent to the correct position andlocked in place. A clamp 181 on the distal end of the positioning device182 is attached to the proximal end of the retractor 180 to hold it inplace and maintain the position of the heart H during the course of thegrafting step.

FIG. 33A shows a side view of an embodiment of a suction heart retractor190 for manipulating the heart within the closed chest of the patient.The retractor 190 has an elongated tubular shaft 191 having a suctioncup-shaped manipulator 192 on the distal end. The suction cup-shapedmanipulator 192 may be mounted straight on the shaft 191 or it may bemounted at an angle to the shaft 191. In one particularly preferredembodiment, there is a 45 degree bend 193 near the distal end of theshaft 191 so that the suction cup-shaped manipulator 192 is mounted at a45 degree angle to the proximal shaft 191. In either embodiment, thesuction cup-shaped manipulator 192 is preferably flexibly mounted to thedistal end of the shaft 191. A vacuum lumen 194 extends through thetubular shaft from the proximal end to the distal end. The distal end ofthe vacuum lumen 194 is in fluid communication with the interior 195 ofthe suction cup-shaped manipulator 192. The proximal end of the vacuumlumen 194 is adapted for attachment to a vacuum source. A fitting forconnecting to the vacuum source, such as a barb fitting or luer fitting,may be attached to the proximal end of the tubular shaft 191, or aflexible extension tube 196 may be attached to the proximal end of theshaft 191 with a fitting at the far end of the extension tube 196.

The shaft 191 of the retractor 190 is preferably made of a rigidmaterial that will support the forces required for manipulating theheart without significant deformation. Acceptable materials for theretractor shaft include stainless steel and liquid crystal polymer. Tofacilitate forming an angled or curved shaft, a mineral filled liquidcrystal polymer (e.g. calcium carbonate) is preferred. This material canbe heat formed at 350 to 400 degrees F.

FIG. 33B shows a longitudinal cross section of the distal end of theheart retractor 190 of FIG. 33A, and FIG. 33C shows a distal end view ofthe heart retractor of FIG. 33A. The suction cup-shaped manipulator 192has an external diameter of approximately 12 to 50 mm for a surface areaof approximately 110 to 1960 mm². The surface area of the suctioncup-shaped manipulator 192 allows a firm grip on the surface of theheart H when a vacuum is applied to the interior 195 of the suction cup192, without causing vacuum damage to the tissue. A valve 197 on theshaft 191 of the retractor 190 allows the surgeon to control the vacuumto turn it on and off. Preferably, the vacuum should be limited to amaximum of 150 mmHg to avoid tissue damage. The suction cup-shapedmanipulator 192 is made of a soft, flexible elastomeric material, suchas silicone rubber with a hardness of approximately 40 to 80 Shore Adurometer. The soft, flexible suction cup-shaped manipulator 192 isdesigned so that when a vacuum is applied within the interior 195 of thesuction cup 192, the suction cup 192 conforms to the surface of theheart H and does not cause deformation of the heart tissue.

The distal surface 198 of the suction cup-shaped manipulator 192 istextured to create a high friction surface. In one particularlypreferred embodiment, the suction cup-shaped manipulator 192 has apattern of bumps 199 on the distal surface 198 and a circular ridge 200around the periphery of the suction cup 192. The bumps 199 in onepreferred embodiment have a height of approximately 1 mm with a 120degree conical end and straight sides. Other geometries for thefriction-increasing bumps 199 include conical, cylindrical orhemispherical, as well as other possible geometries. The circular ridge200 around the periphery has a height of approximately 1-2 mm. Thegeometry and the pattern of the bumps 199 create a reliable frictiongrip on the surface of the heart H under vacuum without causing anydamage to the heart tissue. An alternative embodiment of the retractorhas an absorbent high friction material (not shown) adhesively attachedto or cast into the distal surface of the suction cup-shaped manipulator192 in place of the pattern of bumps. A suitable absorbent high frictionmaterial for this application is a nonwoven polyester fabric embossedwith an open mesh pattern.

In use, the distal end of the retractor 190 is inserted through one ofthe access ports, typically one of the takedown ports 103, 104, 105 inthe left lateral side of the patient's chest. The soft, flexible natureof the suction cup-shaped manipulator 192 allows it to be folded orcollapsed as it is pushed through the access port. The retractor 190 canbe inserted through an access cannula 112 or the cannula 112 can beremoved from the access port 103 to facilitate insertion of the suctioncup-shaped manipulator 192 directly through the access port 103. In onepreferred embodiment of the method, suction cup-shaped manipulator 192is placed on the anterior surface of the heart H near the apex, as shownin FIG. 34, and a vacuum is applied to grip the surface of the heart.From this position, the retractor 192 can be used to rotate the heart Hin either direction. In FIG. 35, the retractor 190 has been used torotate the heart H approximately 90 degrees to the right to expose theCx and the OM branches on the left aspect of the heart to view. Theretractor 190 can also be used to rotate the heart 180 degrees to theleft to expose the RCA and PDA on the posterior aspect of the heart, asin FIG. 8. In an alternative embodiment of the method, the suctioncup-shaped manipulator 192 is placed on the posterior side of the heartnear the apex and a vacuum is applied to grip the surface of the heart.Then, the retractor 190 is used to lift and rotate the heart to flip it180 degrees to expose the RCA and PDA on the posterior aspect of theheart, as in FIG. 7. This retractor 190 can also be fixed to theoperating table to stabilize the heart in the desired position similarlyto the embodiment of FIG. 32.

FIG. 36 shows a third retraction device 210 for manipulating the heartwithin a patient's closed chest. The retraction device 210 has anelongated tubular shaft 211. The tubular shaft 211 has a right anglebend 212 at the distal end. A first end 213 of a flexible snare 214 isattached to the shaft 211 at the distal end. The second end of theflexible snare extends through a lumen within the tubular shaft 211 andattaches to a sliding handle 215 at the proximal end. The snare 214 ismade of a flexible wire or band. Preferably, the flexible wire or bandis covered with a soft, flexible friction material to increase thesurface area and to improve the frictional grip on the heart. Suitablematerials for the covering of the snare include soft, flexible polymersor elastomers or absorbent, high-friction fabrics. The flexible wire orband 214 of the snare is preferably made of a highly resilient materialsuch as a superelastic nickel/titanium alloy or a spring temperstainless steel or titanium alloy.

FIG. 37 shows the heart retractor of FIG. 36 in a predeployed positionfor insertion through an access cannula. When the sliding handle is in aproximal position, the snare 214′ forms a small loop, as shown in FIG.37, which easily deforms to fit through a 10 mm access cannula. When thesliding handle 215 is in a distal position, the snare 215 forms a largeloop 214, as shown in FIG. 36, which is large enough to encircle theheart H. The wire is preferably preshaped so that the snare opens up ina loop 214 perpendicular to the axis of the distal segment 216 of theshaft 211. FIG. 38 shows a cross section of a patient showing theretraction device 210 inserted into the thoracic cavity through one ofthe access ports 103 with the snare encircling the heart H. From thisposition, the retractor 210 can be used to manipulate the heart H to adesired position. For example, the retractor 210 can be used to lift androtate the heart H to flip it 180 degrees to expose the RCA and PDA onthe posterior aspect of the heart, as in FIG. 7.

FIG. 39 shows a fourth retractor device 220 for manipulating the heartwithin the close chest of a patient in a predeployed position forinsertion through an access cannula. The retractor 220 has an elongatedtubular shaft 221 with a handle 226 on the proximal end. In a preferredembodiment, the distal end 222 of the shaft has an angled portion at anapproximately 0 to 45 degree angle to the proximal portion of the shaft221. A flexible band 223 extends through a lumen within the tubularshaft 221 and extends beyond the distal end of the shaft 221. The distalend of the band 223 is pivotally attached to a distal link 224. Thedistal link 224 is, in turn, pivotally attached to a proximal link 225which, in turn, is pivotally attached to the distal end 222 of thetubular shaft 221. The proximal end of the band 223 is attached to asliding actuator button 227 on the handle 226. When the activator button227 is in a proximal position, the distal portion of the flexible band223 is positioned parallel to and in close proximity to be proximal 225and distal links 224, as shown in FIG. 39. When the activator button 227is in a distal position, the distal portion of the flexible band 223extends from the distal end of the tubular shaft 221 to form a loop 228together with the proximal 225 and distal links 224, as shown in FIG.40. In the illustrative embodiment of FIGS. 39 and 40, the handle 226has a semicircular cassette 229 for storage of the band 223 when theband is in the proximal position. Other embodiments of the retractor 220could have a circular storage cassette or a linear configuration forstoring the retracted band 221. Preferably, the flexible band 223 ismade of a resilient material such as a spring tempered stainless steelor titanium alloy. The proximal 225 and distal links 224 are alsopreferably made of a stainless steel or titanium alloy. The surfaces ofthe flexible band 223 and/or the proximal 225 and distal links 224facing the inside of the loop 229 are preferably covered with a soft,flexible friction material to improve the frictional grip a theretractor on the heart H. Suitable materials for the covering of theloop 228 include soft flexible polymers or elastomers or absorbent,high-friction fabrics.

In use, the distal end of the retractor loop 220 is inserted into thethoracic cavity through one of the access ports 103, typically one ofthe takedown ports 103, 104, 105 on the left lateral side of the chest.The actuator button 227 is advanced distally to open the loop 228 largeenough to encircle the heart H. The loop 22 is passed around the heart Hfrom the apex end and tightened gently around the heart, as shown inFIG. 41. A force limiter can be incorporated into the actuatingmechanism of the retractor 220 to prevent excessive force on the heartH. From this position, the retractor 220 can be used to manipulate theheart H to a desired position. For example, the retractor 220 can beused to lift and rotate the heart to flip it 180 degrees to expose theRCA and PDA on the posterior aspect of the heart, as in FIG. 7.

FIGS. 42-45 show a topical hypothermia device 230 which can be used toimprove myocardial protection during the port-access multivessel CABGprocedure. The topical hypothermia device 230 has a flexible heatexchanger 231 which has at least one fluid passage 232 therethrough tocirculate a cooling fluid. The flexible heat exchanger 231 iscollapsible to a predeployed position which can easily fit through anaccess port into the chest of the patient. The flexible heat exchanger231 is attached to the distal end of an elongated tubular shaft 233. Thetubular shaft 233 is preferably made of a rigid material such asstainless steel or a rigid plastic. An inflow lumen 234 extends throughthe tubular shaft 233 and is fluidly connected to the flexible heatexchanger 231. A return lumen 235 extends through the tubular shaft 233parallel to the inflow lumen 234. The inflow lumen 234 and the returnlumen 235 may be formed of extruded plastic tubes which are insertedthrough the tubular shaft 233. Alternatively, the lumens 234, 235 may beformed integrally with the tubular shaft 233 by extrusion. The proximalends of the inflow lumen 234 and the return lumen 235 are adapted forattachment to a circulating pump 236 and a reservoir of cooling fluid237, which is preferably a saline solution.

In the illustrative embodiment of FIG. 42, the flexible heat exchanger231 is made from two sheets of flexible plastic which are heat sealed orRF sealed together to form a serpentine cooling path 232 through theheat exchanger 231. Preferred materials for manufacturing the flexibleheat exchanger 231 include polyurethane, vinyl, polypropylene, nylon,etc. The flexible heat exchanger 231, in one preferred embodiment, has alength of 12-18 cm and a width of 7-10 cm. Optionally, the flexible heatexchanger 231 may have a flexible backbone 238 which extends from thedistal end of the tubular shaft 233 to the distal edge of the heatexchanger 231. The flexible backbone 238 may be made from a flexiblepolymer, elastomer, or a resilient metal wire, such as spring temperstainless steel or a superelastic nickel/titanium alloy, or a compositeof metal and plastic. The flexible heat exchanger 231 is rolled, foldedor twisted and placed in an introducer sheath 239 in the predeployedposition as shown in FIG. 43. Preferably, the introducer sheath 239 issized to fit through an access cannula with a 10-12 mm internaldiameter.

In use, the topical hypothermia device 230 is prepared in thepredeployed position by first priming the flexible heat exchanger 231 byfilling it with cooling fluid and connecting the proximal end of theinflow lumen 234 and the return lumen 235 to the circulating pump 236and the reservoir of cooling fluid 237. The flexible heat exchanger 231is rolled and covered with the introducer sheath 239. The topicalhypothermia device 230 is inserted through one of the access ports 104in this predeployed position. The distal end of the introducer sheath239 is placed under the heart H and then withdrawn proximally withrespect to the flexible heat exchanger 231, thereby placing the flexibleheat exchanger 231 underneath the heart H. Alternatively, the sheath 239can be withdrawn after the topical hypothermia device 230 is introducedthrough the access port 104 and the flexible heat exchanger 231 placedunder the heart H with the help of the flexible backbone 238. Thecirculating pump 236 is turned on to force cooling fluid into theflexible heat exchanger 231 and through the cooling passage 232. Theflexible heat exchanger 231 inflates with cooling fluid and spreads outunder the heart H to make good thermal contact with the myocardium, asshown in FIG. 45. Preferably, the flexible heat exchanger 231 isconstructed so that it curves to conform to the exterior of the heart Hwhen inflated to the deployed position, as shown in FIG. 44, to create abetter thermal contact with the myocardium. Typically, a cooling fluidat 0-4 degrees Celcius is circulated through the flexible heat exchanger231 with a flow rate of greater than 350 ml/min to rapidly cool theheart.

In an alternate embodiment of the topical cooling device, the flexibleheat exchanger 231 may also be covered with a thermal insulatingmaterial, such as surgical felt, to prevent thermal shock to themyocardial tissue. Another way to avoid thermal shock to the myocardialtissue is to use a more moderate temperature for the cooling fluid, withbetter thermal contact and a higher flow rate to rapidly cool themyocardium without the risk of thermal shock.

FIG. 46 shows an alternate embodiment of the topical cooling device 240,which is similar to the embodiment of FIG. 42 except for theconstruction of the flexible heat exchanger 241. In this embodiment, theflexible heat exchanger is in the form of a ring made by heat sealingtwo sheets of plastic together. The cooling fluid enters one side of thering-shaped heat exchanger and follows a serpentine cooling path 242through the heat exchanger 241 around to the other side of the ring. Apreformed, resilient wire loop 248 is attached around the outside of thering-shaped heat exchanger 241 to initialize the shape of the heatexchanger 241 during deployment, as shown in FIG. 47.

The topical cooling device 230, 240 can be used alone to inducehypothermic cardiac arrest in the patient's heart or the topical coolingdevice 230, 240 can be used in conjunction with cardioplegic arrest toimprove the myocardial protection during the surgical procedure. Inaddition, the topical cooling device 230, 240 can be used to rewarm theheart after the completion of the surgical procedure by circulating warmfluid through the flexible heat exchanger 231, 241. In addition to themultivessel CABG procedure of the present invention, the topical coolingdevice 230, 240 will find utility for improving myocardial protection inany open-chest or closed-chest cardiac surgery.

Another closely related surgical approach for performing closed-chestmultivessel CABG surgery is through an anterior mediastinotomy, that is,through an incision into the mediastinum, the mass of tissues and organsbetween the lungs that includes the heart. Another term for thissurgical approach is a rib-sparing, anterior mini-thoracotomy. There aretwo ways to perform the anterior mediastinotomy for this approach. Thefirst way is through an intercostal incision 250, 25-50 mm long, in thefourth I4 or fifth I5 intercostal space to the left of the sternum S, asshown in FIG. 48. The second way is to create a larger access port 260by removing either the third C3, fourth C4 or fifth C5 costal cartilage,preferably on the left side of the sternum S. When one of the costalcartilages is removed, it creates an access port 260 approximately 50-60mm square, as shown in FIG. 49. The access port 260 can be held openusing a tissue spreader for an access cannula which is oval or square inshape. Actual cutting or removal of ribs is not necessary. The bestposition for the port may be decided by viewing through the lateral IMAtakedown ports in the third or fourth intercostal space and probing witha needle to find the best position and line of sight for the particularanastomosis site. It should be noted that, because the anteriormediastinotomy may cut across the path of the internal mammary artery,it is preferable to make the access port after completion of the IMAtakedown.

A tissue spreader or oval cannula 251 for retraction would be useful tomaintain the access channel. Retraction of the ribs should be kept to aminimum in order to reduce the trauma to the patient. For introductionwithout retraction of the ribs, the oval cannula 251 should haveinterior dimensions of approximately 12 mm width and 25-50 mm length,and a thin wall of approximately 1 mm thick. For varying degrees ofretraction, the width of the oval cannula 251 can be increased anywherefrom 12 mm to 25 mm, which should be sufficient for adequatevisualization and instrument access. Visualization and instrumentinsertion can thus be accomplished through a single elongated accessport, rather than using separate visualization and instrument ports asin the port-access approach described above. Visualization can beaccomplished using a surgical microscope, as described above, or bydirect visualization through the access port 250, 260, with or withoutmagnifying loupes. The cannula 251 should be configured to facilitateretraction of the pedicle through the lumen of the cannula without harmso that the distal end of the graft vessel can be prepared foranastomosis outside of the body under direct visualization. Therefore,the cannula 251 should have no sharp edges that could harm the graftvessel or pedicle. The insertion length of the cannula 251 should beabout 25-50 mm.

Preferably, illumination means are incorporated into the oval cannula251 or into the tissue spreader used to maintain the access channel. Alight conduction path is incorporated into the wall of the oval cannula251 or into the blades of the tissue spreader to direct a beam of lightdistally onto the surgical site. A light source is connected to thelight conduction path. The light source can be integrated into thedevice or an external light source may be connected to the device by anoptical cable.

An exemplary embodiment of an illuminated access device is shown in atop view in FIG. 50 and a side view in FIG. 51. This particularembodiment is an illuminated oval cannula 251, however the followinginventive features can also be incorporated into a blade retractor,tissue spreader, or standard circular access cannula. Optical fibers 252are embedded into the wall of the oval cannula 251. The optical fibersterminate at the distal end of the cannula 251 to direct a beam of lightdistally toward the surgical site. A narrow or diffuse beam of light canbe created depending on the arrangement and the numerical aperture ofthe optical fibers. At the proximal end of the cannula 251, the opticalfibers 252 gather together into an optical connector 253 for connectionto an external light source. In one currently preferred embodiment, amultiplicity of small diameter optical fibers are distributed evenlyabout the periphery of the oval cannula 251. The wall of the ovalcannula 251 can be made of an opaque material to avoid light escapingfrom the optical fibers 252 from interfering with visualization throughthe lumen 254 of the cannula 251. Alternatively, the interior and/orexterior wall of the cannula 251 can be made transparent or translucentto create a diffuse ambient light within or around the cannula 251.

Anastomosis between the graft vessel and the coronary artery isperformed using instruments inserted through the access port 250, 260.One advantage of this approach is that the access port 250, 260 is largeenough so that the surgeon can insert a finger through the access portor oval cannula 251 to directly palpate the heart, for instance tolocate a stenosis in the coronary artery. It may be advantageous toelevate the heart within the thoracic cavity to facilitate palpation ofthe heart and/or performing the anastomosis. A device similar to thetopical cooling devices 230, 240 of FIGS. 42-47 may be used to elevatethe heart H within the thoracic cavity by inserting it underneath theheart and inflating it, with or without circulating cooling fluid. Thetunneling and retraction devices of FIGS. 22-41 can be used through theaccess port or through the takedown ports to manipulate the heart toexpose different aspects of the heart for visualization and anastomosisof multiple coronary arteries according to the methods described above.Alternatively, a second mediastinal access port 250′, 260′ can be openedon the right side of the chest to access the right coronary arterydirectly. In another alternative approach, a right side mediastinalaccess port 250′, 260′ may be used alone if only the right coronaryartery is to be revascularized or if the patient's anatomy favors aright side approach for multivessel revascularization.

What is claimed is:
 1. A method of holding a patient's heart in adesired orientation to expose areas of the heart for performing aprocedure on the heart, comprising the steps of: providing a heartengaging device having a suction element, the suction element beingcoupled to a vacuum source to adhere the suction element to a patient'sheart; creating an opening into a patient's thoracic cavity; passing aportion of the heart engaging device through the opening; contacting theheart with the suction element; applying suction with the vacuum sourceso that the suction element adheres to the surface of the heart; andholding the heart in a desired orientation to expose part of the heartfor performing a procedure on the heart.
 2. The method of claim 1,further comprising the step of: manipulating the heart with the heartengaging device to the desired orientation.
 3. The method of claim 2,wherein: the manipulating step is carried out by lifting the heart withheart engaging device.
 4. The method of claim 2, wherein: themanipulating step is carried out by rotating the heart with theheartengaging device.
 5. The method of claim 4, wherein: the manipulatingstep is carried out by rotating and lifting the heart with the heartengaging device.
 6. The method of claim 1, wherein: the providing stepis carried out with the heart engaging device being suction-cup shaped.7. The method of claim 6, wherein: the providing step is carried outwith the suction element being a single suction-cup.
 8. The method ofclaim 6 or 7, wherein: the providing step is carried out with thesuction-cup shaped element having an external diameter of 12-50 mm. 9.The method of claim 6 or 7, wherein: the providing step is carried outwith the suction-cup shaped element having a surface area ofapproximately 110 to 1960 mm squared.
 10. The method of claim 6 or 7,wherein: the providing step is carried out with the suction-cup shapedelement having a circular ridge about a periphery.
 11. The method ofclaim 10, wherein: the providing step is carried out with the circularridge having a height of 1-2 mm.
 12. The method of claim 6, wherein: theproviding step is carried out with the suction-cup shaped element havingan internal surface, the internal surface having a raised portion. 13.The method of claim 12, wherein: the providing step is carried out withthe raised portion taking a form selected from the group consisting ofconical, cylindrical and hemispherical geometries.
 14. The method ofclaim 1 or 6, wherein: the providing step is carried out with thesuction-cup shaped element being made of an elastomeric material. 15.The method of claim 14, wherein: the providing step is carried out withthe suction cup-shaped element being made of a material having 40-80Shore A durometer.
 16. The method of claim 1, wherein: the providingstep is carried out with the suction element being flexible and whereinthe suction element conforms to the shape of the heart when suction isapplied by the suction source.
 17. The method of claim 1, wherein: theproviding step is carried out with the suction element being coupled toa shaft.
 18. The method of claim 2, wherein: the providing step iscarried out with the shaft being bent.
 19. The method of claim 2,wherein: the providing step is carried out with the vacuum source beingcoupled to a vacuum lumen which extends through the shaft.
 20. Themethod of claim 6, wherein: the suction-cup shaped element has a distalsurface; and the providing step is carried out with an absorbentmaterial on the distal surface.
 21. The method of claim 1 or 6, wherein:the contacting step is carried out with the suction element being placedon an anterior surface near the apex of the heart.
 22. The method ofclaim 21, further comprising the step of: rotating the heart to exposethe posterior aspect of the heart, wherein the heart engaging deviceholds the heart in a rotated position.
 23. The method of claim 22,wherein: the rotating step is carried out by manipulating the heart withthe heart engaging device to rotate the heart.
 24. The method of claim1, wherein: the contacting step is carried out with the heart engagingdevice being placed on a posterior side of the heart near the apex. 25.The method of claim 24, further comprising the step of: rotating theheart to expose the posterior aspect of the heart, wherein the heartengaging device holds the heart in a rotated position.
 26. The method ofclaim 25, further comprising the step of: lifting the heart, wherein theheart engaging device holds the heart in an elevated position.
 27. Themethod of claim 26, wherein; the lifting step is carried out to exposethe posterior aspect of the heart.
 28. The method of claim 26, wherein:the lifting step is carried out by manipulating the heart with the heartengaging device.
 29. The method of claim 1, further comprising the stepof: securing the heart engaging device to a fixed structure.
 30. Themethod of claim 29, wherein: the securing step is carried out with theshaft being fixed to the operating table.
 31. The method of claim 1,further comprising the steps of: lifting and rotating the heart toexpose a posterior aspect of the heart.
 32. The method of claim 31,wherein: the contacting step is carried out by manipulating the heartnear the apex.
 33. A method of manipulating a patient's heart,comprising: providing a retractor comprising a manipulator having aninterior, the interior being in fluid communication with a suctionsource; creating an opening into a patient's thoracic cavity; passingthe manipulator through the opening; placing the manipulator on asurface of the heart; applying a vacuum to the interior of themanipulator via the suction source such that the manipulator grips thesurface of the heart; and positioning the heart with the retractor to aposition other than the heart's native position.
 34. The method of claim33, wherein the positioning step comprises rotating the heart.
 35. Themethod of claim 34, wherein the positioning step comprises rotating theheart to expose one of the circumflex artery, the right coronary artery,the posterior descending artery and the obtuse marginal artery.
 36. Themethod of claim 33, wherein the manipulator is flexible and themanipulator is folded or collapsed as it is passed through the opening.37. The method of claim 33, wherein the manipulator does not causedeformation of the heart tissue when it grips the heart tissue.
 38. Themethod of claim 33, wherein the manipulator is flexible and themanipulator conforms to the heart surface when suction is applied viathe suction source.
 39. The method of claim 33, comprising fixing theretractor to stabilize the heart in a desired position.
 40. The methodof claim 33, wherein the positioning step comprises positioning theheart to a position that facilitates the performance of a surgicalprocedure.